*Sac-TMT + pembro ± bevacizumab as 1L maintenance for cervical cancer

  • Research type

    Research Study

  • Full title

    A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as First-line Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

  • IRAS ID

    1012701

  • Contact name

    - -

  • Contact email

    N/A

  • Sponsor organisation

    Merck Sharp & Dohme LLC

  • Clinicaltrials.gov Identifier

    NCT07216703

  • Research summary

    Researchers are looking for new ways to treat metastatic cervical cancer.

    The standard treatment for metastatic cervical cancer includes first treatment of chemotherapy with or without immunotherapy or targeted therapy.
    After first treatment, people may get maintenance treatment to keep the cancer from growing, spreading or coming back. Pembrolizumab with or without bevacizumab is standard maintenance treatment.

    Researchers want to learn about giving the trial medicine sacituzumab tirumotecan (sac-TMT or MK-2870) as maintenance treatment with pembrolizumab and bevacizumab. Sac-TMT is a type of medicine that attaches to cancer cells and delivers treatment to destroy those cells.

    About 1023 people (assigned female at birth) aged 18 years or older will be in this trial and:
    • Have persistent, recurrent or newly diagnosed metastatic cervical cancer
    • The cancer cannot be completely removed with surgery or radiation
    • Do not have certain heart problems

    This trial has 2 parts:
    Part 1: About 20 people will receive sac-TMT, pembrolizumab and bevacizumab as maintenance treatment for up to 1 year and 8 months. Researchers will check for any safety concerns before starting Part 2.

    Part 2: About 1000 people will receive first treatment of pembrolizumab and chemotherapy with or without bevacizumab for up to 5 months. People who had cancer respond to first treatment and meet certain criteria will receive maintenance treatment for up to 1 year and 8 months. Researchers will assign them by equal chance to:
    • Group 1: Sac-TMT and pembrolizumab with or without bevacizumab
    • Group 2: Pembrolizumab with or without bevacizumab
    People who do not have cancer respond to the first treatment or do not meet certain criteria may have the option to receive more treatment with one or more of the trial treatments.

    A person may be in this trial for about 7 years.

  • REC name

    London - Westminster Research Ethics Committee

  • REC reference

    25/LO/0677

  • Date of REC Opinion

    5 Nov 2025

  • REC opinion

    Further Information Favourable Opinion